Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

User Fee Forecast For May: Approvals Could Sprout In Multiple Divisions

Executive Summary

Aimovig, Andexxa, Lucemyra, and pegvaliase are among the almost 20 products with upcoming user fee goals at US FDA this month.

You may also be interested in...



As Amgen Looks To Aimovig's Launch, It May Learn From Repatha's Past

Amgen started 2018 off on solid footing with a 2% jump in Q1 revenue to $5.55bn versus consensus estimates of $5.4bn, but new drugs like the CGRP inhibitor Aimovig are needed to keep the momentum going and supplement declining sales for key products.

Lofexidine Gets US FDA Panel Nod For Mitigating Opioid Withdrawal Symptoms

But Psychopharmacologic Drugs Advisory Committee says US WorldMeds' second proposed indication for facilitating completion of opioid discontinuation treatment is not supported by data from two short-term studies in an 'idealized' population.

Portola May Need Randomized Trial For AndexXa Approval. The Question Is When

Randomized trial represents higher bar for US approval of reversal agents for novel anticoagulants than expected – and if needed prior to approval, could delay AndexXa launch for two or maybe even four years.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS123017

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel